Behind the Scenes of an Investigation with EIS Officer Erin Blau

Behind the Scenes of an Investigation with EIS Officer Erin Blau


[Applause] I was so excited to match to a state assignment,
especially one in the heart of bluegrass country where I Drive past horse farms like these
every day on my way to work. I knew a state assignment would give me the
opportunity to explore a variety of public health topics. But what I did not know was that within months
of arriving to my assignment I would be leading one of the most unique, confusing, and challenging
investigations the health department had ever seen. It was December, halfway through Fall Course,
when I received a distressed call from my supervisor. He was calling to let me know that a physician
was reporting three abscess-like reactions following vaccination. I could sense the worry in his voice. To put things in context, it was the middle
of flu season and there were a few other things going on in Kentucky around this time. We worked with the local health department
and identified that these three individuals received their vaccines from the same business,
Business A. We reached out to this business and their owner – let’s call her Ms. Smith
– and ask them to cease all vaccination and set aside any remaining vaccine. By the end of the week the local health department
was onsite. The local health department collected all
remaining vaccine, but all that remained were six pre-drawn syringes. Now I do want to clarify when I say pre-drawn
I’m referring to the fact that someone has drawn up vaccine into a syringe from a multi-dose
vial, much like the one you see here. And while use of a multi-dose vial is standard,
vaccine should only be drawn up immediately before administration. So to collect vaccine that was already drawn
up into syringes, this seemed highly unusual. We scheduled our visit to the business the
following week. Unfortunately we were not able to directly
observe any vaccine handling or storage as when we arrived on site Ms. Smith let us know
that she had contacted the CDC nearly one month earlier to report these reactions and
that when she contacted the CDC they advised her to throw away everything – vaccine, syringes,
supplies – all of it. Thankfully those calls are recorded and interestingly
enough no one tells her to discard vaccine or anything for that matter. But maybe she was confused? Unable to directly observe the storage and
handling, we asked Ms. Smith to walk us through her hand hygiene. Providing vaccines in a variety of settings,
she reports that she doesn’t always have access to sink or soap and water so she has to use
other methods. That makes sense. Ms. Smith proceeds to reach out to a nearby
drawer and pull out two alcohol pads, much like the ones you see here. I looked on in disbelief as she proceeded
to rip open the alcohol wipes and rub the two-by-twos across her hand. She said this is how she cleaned her hands
most often. Lack of temperature monitoring, lack of thermostats
or thermometers at all, reporting of drawing up syringes of vaccine days to weeks before
administration, and the use of a dormitory-style refrigerator with no backup power source we
had serious concerns on how effective this vaccine was. Our next logical question was to ask Ms. Smith
about her background and training. She initially answers with nursing. It takes multiple follow-up questions to uncover
that this background in nursing is no licensed degree or certification. No, it’s far less. It’s that she was trained by a nurse, once,
years ago which now left everyone on our investigation team wondering who exactly is allowed to vaccinate
in the state of Kentucky? Business A is owned and operated by Ms. Smith’s
husband – let’s call him Dr. Smith – has his own primary care clinic and reports having
minimal involvement in Business A however all vaccine for Business A is ordered and
administered under his medical license. Business A travels to different company work
sites in their area and vaccinates employees at no cost to the employer, allowing these
individuals to receive necessary vaccines without having to miss work. Ms. Smith reports that she is the only person
who prepares and administers vaccines and that she alone traveled to seven companies
between September and December of 2018 and vaccinated. We reached out to these companies. Six of the seven companies reported one location
and that location was in Kentucky. I remember calling the seventh company and
speaking with the HR manager. He let me know that they had 17 locations. I had to ask for clarification. Did he mean to say that Business A traveled
and vaccinated at 17 of their locations? He answered affirmatively. Two in Indiana, eleven in Ohio, and four in
Kentucky. And just like that our investigation was now
multi-state. In talking with the companies we also found
out that there were three other individuals who would arrive onsite and vaccinate employees,
contradicting Ms. Smith’s previous claims to be the one and only person who vaccinated. It should also be noted that around this time
we started to receive positive results. Individuals who were experiencing reactions
and infections were seeking care, and their physicians and medical providers were testing
their infections. These cultures were coming back positive for
a bacteria, non-tuberculous mycobacterium– or mycobacterium fortuitum. To be more specific, the significance behind
this being that this bacteria tends to be found in water and has been associated with
tap water in previous health care setting outbreaks. We had a few ideas on what might have been
happening but we didn’t want to rush to any conclusions. We did however want to re-interview Ms. Smith
and we wanted to collect some environmental samples so we were back at the clinic the
following week. I want to take a pause here because if you
are confused, know that you are not alone. This was easily the most confusing part of
the investing for me. I had so many questions and I went into the
second visit wanting answers. Sure, call me naive but up until this point
I was trying to give Ms. Smith the benefit of the doubt. For me it was very personal. As a nurse practitioner I’ve administered
countless vaccines. I know its complexity and I take it very seriously. I would be heartbroken to find out that patients
of mine were getting sick after I had vaccinated them and I would be devastated if a health
department thought I was to blame. Sure, Ms. Smith was not a nurse like I was
– that was clear – but she was trying to care for people and I wanted to be wrong. Unfortunately after this second visit there
was no going back. It was clear that these inconsistencies were
more than just a coincidence and two things made that very clear. First, when we arrived on site we began a
second interview. Because we knew the names of these three other
vaccinators, I asked Ms. Smith who one of them was. Staring straight at me she said she didn’t
know anyone by that name. Now before this interview our investigation
team had looked at Ms. Smith’s public Facebook page and the very person she just denied knowing
was all over her account in pictures and in posts. But even that would prove only to be the second
most important thing we learned that day. Following the interview we proceeded to prepare
to collect samples around the clinic Ms. Smith went back to her office and advised us to
swab anything and everything. Our team moved from room to room, collecting
samples from countertops, sinks, refrigerators – anywhere and everywhere Ms. Smith reported
storing or handling vaccine. As we moved into the second room something
else caught our eye. Beyond an open doorway in a dark side room
there was another refrigerator but this one was different, dorm-style as well, but Ms.
Smith had never mentioned it and up until this point we didn’t even know that it existed. I was hit with a wave of emotion. I was terrified but also intrigued. What is this refrigerator and what is inside
of it? Should I go ask her or should I just open
it? So I opened it. Paralyzed by what I might have just found,
I immediately shut the door. My chest was tight, I could barely catch my
breath, and my fingertips they felt like they were going numb. I was in shock at what I might have just seen. I had to open it again. I had to know if these boxes contain the very
same vaccine that Ms. Smith had reported being supposedly told to discard. Sure enough, that’s exactly what I found-
hepatitis A, hepatitis B, Tdap, pneumococcal, expired yellow fever, and various forms and
amounts of sodium chloride. Now I would like to say that I played it cool
and I knew exactly what to do next, but that’d be a big fat lie. I did not expect the visit to go like this,
and I most certainly did not know how to handle this situation. So I found an empty room in the back corner
of the clinic. I crouched down and huddled against the furthest
wall, frantically swiped through my phone until I found my supervisors number and proceeded
to convey my dilemma through whispers. My mind was moving a mile a minute. Was I even making sense? Apparently I was. I listened as my supervisor ran down the hallway
to the health commissioner’s office, phone in-hand, and breathlessly explained the situation. I was asked to not only swab the newly discovered
refrigerator but collect all the vaccine. After I gave myself a quick pep talk as I’m
sure all officers do on their first outbreak investigation I confronted Ms. Smith. She was understandably stunned when I told
her I had found vaccine. She ran to the refrigerator claiming it was
all expired and needed to be sent back to the manufacturer for credit, but it wasn’t
and I told her that. Our concerns continued to grow as we began
to receive results from those syringes that were collected at the beginning of the investigation. Two of the six syringes grew multiple organisms,
and an additional two of the six syringes had antigen levels well below what would be
expected in a vaccine dose. One of them was 50-fold less than the control. On top of that a community provider reached
out to the health department and let us know that he had seen five patients who reported
receiving hepatitis A vaccines from Business A. In caring for these patients he tested
for immunity and reported that none of these five patients showed any signs of immunity
to hepatitis A. This was enough. The Kentucky Department for Public Health
issued a press release. Following this press release and a later interview
with one of the additional vaccinators, we identified 23 companies with over 54 locations
across all three states. We estimate that over a thousand individuals
receive vaccines from Business A during the fall of 2018. We identified over a hundred individuals who
experienced one or more reactions following vaccinations from Business A, and we identified
over 25 individuals who tested positive for mycobacterium fortuitum – all with indistinguishable
PFGE patterns indicating one common source. Now when I moved to Kentucky I thought I knew
what I was going to be getting myself into – hepatitis A, opioid overdose prevention,
surely a foodborne outbreak, and maybe even try my hand at chronic diseases. But never in my wildest dreams did I think
I’d be out swabbing a refrigerator and persuading a business to turn over likely contaminated,
definitely ineffective, and most certainly concealed vaccine. Ready to respond anywhere in the world at
a moment’s notice takes on a whole new meaning, and I couldn’t be more grateful. Thank you. [Applause]

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